NCT02065284

Brief Summary

Rhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve patients' movements, especially when walking. The purpose of this study is to compare the effect on walking performance of a home based walking program (HBWP) with Rhythmic Auditory Stimulation (RAS), to that of a HBWP without RAS, or to RAS without walking exercise. A second part of this study will assess the effects of Rhythmic Auditory Stimulation (RAS) on brain activity in patients with Multiple Sclerosis while performing mental imagery of walking.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

1.6 years

First QC Date

February 13, 2014

Last Update Submit

June 15, 2022

Conditions

Multiple SclerosisAmbulation Difficulty

Keywords

MSAmbulation

Outcome Measures

Primary Outcomes (1)

  • Improved gait pattern on gait analysis

    To compare the effect on gait pattern of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.

    8 weeks

Secondary Outcomes (2)

  • Improved walk time on the timed 25 foot walk test

    8 weeks

  • Improved distance on the 2 minute walk test

    8 weeks

Other Outcomes (1)

  • To assess changes in cortical activation induced by Rhythmic Auditory Stimulation in Multiple Sclerosis patients performing mental imagery of walking.

    8 weeks

Study Arms (3)

Walking-Rhythmic Auditory Stimulation

ACTIVE COMPARATOR

Walking daily with Rhythmic Auditory Stimulation (RAS) based music for 4 weeks

Other: Rhythmic Auditory Stimulation (RAS)

Walking- only

ACTIVE COMPARATOR

Walking daily with no Rhythmic Auditory Stimulation (RAS) based music for 4 weeks

Other: Rhythmic Auditory Stimulation (RAS)

Rhythmic Auditory Stimulation (RAS)only

ACTIVE COMPARATOR

Listening to based music only daily for 4 weeks

Other: Rhythmic Auditory Stimulation (RAS)

Interventions

Rhythmic Auditory Stimulation (RAS)OTHER

Rhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve patients' movements, especially when walking.

Also known as: RAS
Rhythmic Auditory Stimulation (RAS)onlyWalking- onlyWalking-Rhythmic Auditory Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years or older
  • diagnosis of MS per Mc Donald criteria
  • Ambulation Index score from 2 to 6 inclusive (clinically observable gait disturbance, whether the subject walks with no, unilateral, or bilateral support)
  • spastic paresis is the main neurologic impairment causing the gait disturbance, per investigator's judgment.

You may not qualify if:

  • neurologic impairments other than spastic paresis (e.g. cerebellar ataxia or sensory ataxia), or non-neurologic impairments (e.g. musculoskeletal problems) play a major role in the subject's gait disturbance, per investigator's judgment;
  • treatment for an MS exacerbation in the past 30 days;
  • severe co morbidity precluding participation in the study per investigator's judgment (e.g. severe cardiac or respiratory failure);
  • severe cognitive deficits precluding informed consent or preventing the subject from following study procedures safely
  • contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Neurological Institute Mellen Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • Conklyn D, Stough D, Novak E, Paczak S, Chemali K, Bethoux F. A home-based walking program using rhythmic auditory stimulation improves gait performance in patients with multiple sclerosis: a pilot study. Neurorehabil Neural Repair. 2010 Nov-Dec;24(9):835-42. doi: 10.1177/1545968310372139. Epub 2010 Jul 19.

    PMID: 20643882BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisMobility Limitation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Francois A Bethoux, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 19, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations

US(1)